MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-07-16 for SPIDER WRIST FUSION SYSTEM 07-0005 manufactured by Kinetikos Medical, Inc..
[293002]
In july 2003, k. M. I. Was notified of the explant of a wrist fusion system from a pt 6 months after its original implant date to address continuous, low level pain. The pt admitted to having subjected the operative limb to extreme stress loading within two weeks of the implant date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028840-2003-00023 |
| MDR Report Key | 472911 |
| Report Source | 05,06 |
| Date Received | 2003-07-16 |
| Date of Report | 2003-07-15 |
| Date of Event | 2003-07-08 |
| Date Added to Maude | 2003-07-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 6005 HIDDEN VALLEY RD STE. 180 |
| Manufacturer City | CARLSBAD CA 92009 |
| Manufacturer Country | US |
| Manufacturer Postal | 92009 |
| Manufacturer Phone | *4481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER WRIST FUSION SYSTEM |
| Generic Name | ORTHOPAEDIC WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 2003-07-16 |
| Model Number | 07-0005 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 461764 |
| Manufacturer | KINETIKOS MEDICAL, INC. |
| Manufacturer Address | 6005 HIDDEN VALLEY RD. STE 180 CARLSBAD CA 92009 US |
| Baseline Brand Name | SPIDER WRIST FUSION SYSTEM |
| Baseline Generic Name | ORTHOPAEDIC WRIST IMPLANT |
| Baseline Model No | 07-0005 |
| Baseline Catalog No | NI |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-16 |